A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML

Exclusion Criteria

• •1.Diagnosed as APL and manifested as t(15;17)(q22;q12) chromosomal translocation, or BCR-ABL positive leukemia；Diagnosed as secondary to AML due to previous chemotherapy or radiotherapy of other tumors; previously received FLT3 inhibitor.
• •2.AML secondary to myeloproliferative tumor (MPN) or acute lymphoblastic leukemia (ALL).
• •3.Subjects who have infiltrated the central nervous system in the past or present.
• •4.Concomitant with other malignant tumors within 5 years before the first medication.
• •5.Thrombosis or embolism occurred within 12 months before the first medication. 6.Pulmonary function tests indicate that subjects have DLCO ≤50% or FEV1 ≤60%, or have difficulty breathing during rest or require continuous oxygen inhalation.
• •7.Subjects with uncontrollable, active infections。 8.Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects undergoing total gastrectomy。 9.Subjects with a history of psychotropic drug abuse and unable to quit or those with mental disorders。 10.Researchers believe that those who have other severe acute or chronic diseases who are not suitable for participating in clinical trials.